Bristol-Myers Squibb takes Opdivo to China's FDA after lung cancer survival win

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Bristol-Myers Squibb has filed for Chinese approval of Opdivo in lung cancer.

Bristol-Myers Squibb is still searching for an Opdivo approval in the all-important first-line lung-cancer space. But in the meantime, it Friday touted strong results in previously treated Chinese patients.

The New Jersey drugmaker cut short a phase 3 trial pitting its immuno-oncology star against chemo docetaxel after Opdivo showed it could top docetaxel at improving overall survival in lung cancer, the company said Friday. And based on those results, Bristol submitted a Biologics License Application for Opdivo to the China Food and Drug Administration.

It’s a big opportunity for Bristol, which now has the potential to score the first non-small cell lung cancer approval for an immuno-oncology therapy in China. There, lung cancer is the most commonly diagnosed cancer; the country recorded 733,000 new cases in 2015, BMS says. And 68% of Chinese patients already have advanced forms of the disease at the time of diagnosis.

RELATED: BMS loses its lung cancer lead to Merck as Opdivo data come up short

Bristol-Myers, which is battling rivals Merck and Roche in the U.S. lung-cancer space, certainly wouldn’t mind having the Chinese market all to itselfat least for now. The company, which once led the way among immuno-oncology drugmakers in lung cancer, ceded that title to Merck last year after flopping in a first-line study. Merck went on to win a pair of front-line approvals for Keytrudaboth solo and in tandem with chemoand now, all eyes are on Bristol to see if it can regain its footing with a first-line Opdivo-Yervoy combo win.

RELATED: Bristol-Myers' Opdivo drives another top-line beat in Q3, but lung-cancer combo data looms

Elsewhere in the world, Opdivo raised eyebrows Friday after triggering an unexpected effect in a Paris-based lung cancer patient with HIV. The cancer-fighter prompted a “drastic and sustained decrease” in the patient’s reservoirs of HIV infection, researchers wrote in a letter published in Annals of Oncology and seen by Bloomberg.